Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia

NCT01723644 | Completed

• 1 other identifier: RC12_0151
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 15

Brief Summary

CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.

Conditions

Community-acquired Pneumonia

Keywords

antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment

Outcome Measures

Primary Outcomes (1)

• duration of antibiotic therapy expressed in days of therapy

  antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes

  Between Day 1 and Day 30

Secondary Outcomes (1)

• clinical success at Day 30

  Day 30

Study Arms (2)

PCT guidance

OTHER

Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT

Other: the procalcitonin arm

clinical reassessment

OTHER

Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT.

Other: the clinical reassessment arm

Interventions

the clinical reassessment arm OTHER

In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America

clinical reassessment

the procalcitonin arm OTHER

In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.

PCT guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• age ≥ 18 years
• admittance from the community or a nursing home with the main diagnosis of community-acquired pneumonia justifying urgent antibiotherapy prescription, hospitalization for at least 6 hours after randomization and chest radiograph compatible with the diagnosis of CAP( Community acquired pneumonia )

You may not qualify if:

• the inability to give written informed consent
• hospitalization \>24 hours
• aspiration pneumonia
• nosocomial pneumonia
• purulent pleurisy
• exacerbation of COPD (chronic obstructive pulmonary disease)
• neutropenia (\<1G/L cells)
• chronic infection with current antibiotherapy
• antibiotherapy before admission for the current infection
• immunosuppression (including prolonged corticotherapy (10 mg of prednisone per day for at least one month)
• active neoplastic disease, organ transplant, pregnancy, HIV diagnosis with a CD4 count\<200 cells/μL.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (15)

University hospital of Agen

Agen, France

Location

University Hospital of Angers

Angers, France

Location

University Hospital of Brest

Brest, France

Location

University Hospital of Clermont-Ferrand

Clermont-Ferrand, France

Location

University Hospital of Grenoble

Grenoble, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

University Hospital of Lille

Lille, France

Location

CHU de Nantes

Nantes, France

Location

University Hospital of Bichat Paris

Paris, France

Location

University Hospital of Bobigny Paris

Paris, France

Location

University Hospital of Hôtel-Dieu Paris

Paris, France

Location

University Hospital of Saint Antoine Paris

Paris, France

Location

University Hospital of Rennes

Rennes, France

Location

University Hospital of Strasbourg

Strasbourg, France

Location

University Hospital of Tours

Tours, France

Location

Related Publications (1)

• Montassier E, Javaudin F, Moustafa F, Nandjou D, Maignan M, Hardouin JB, Annoot C, Ogielska M, Orer PL, Schotte T, Bouget J, Agha Babaei S, Raynal PA, Eche A, Duc AT, Cojocaru RA, Benaouicha N, Potel G, Batard E, Talan DA. Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial. Ann Emerg Med. 2019 Oct;74(4):580-591. doi: 10.1016/j.annemergmed.2019.02.025. Epub 2019 Apr 11.

  PMID: 30982631 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Emmanuel Montassier

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

FR (15)